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This was a Phase III, open-label, single-arm study that was conducted at 43 centers in the United States and Canada. 251 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were enrolled in the study and treated with one or two doses of tenecteplase.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenecteplase | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tenecteplase | Drug | 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of tenecteplase (i.e., 2 mg of tenecteplase). Patients weighing < 30 kg received instillations of tenecteplase equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Had Cumulative Restoration Rates of Central Venous Catheter (CVC) Function Following a Single Administration of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 120 minutes after first dose |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Barbara Gillespie, M.D., FASN | Quintiles, Inc. | Study Director |
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Five patients were randomized but not treated, therefore the modified intent to treat (MITT) analysis population was 246.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tenecteplase | 2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| At Least One Dose of Tenecteplase (MITT) |
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| ||||||||||||||||||
| 48- to 96-Hour Follow-Up Period |
| |||||||||||||||||||
| 7-Day Post-Treatment Contact |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tenecteplase | 2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Who Had Cumulative Restoration Rates of Central Venous Catheter (CVC) Function Following a Single Administration of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | percentage of participants | 120 minutes after first dose |
|
The period during which SAEs and non-serious AEs were recorded began at the initiation of study treatment and ended at the follow-up visit 48-96 hours after treatment or at subject discontinuation from the study, whichever was earlier.
Modified intent to treat (MITT) population.
Note: The incidence of each AE/SAE is reported as the number of participants experiencing the event, not the number of occurrences for each AE/SAE.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tenecteplase | 2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pyrexia | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Neutropenia | Blood and lymphatic system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Genentech, Inc. | 800-821-8590 |
| ID | Term |
|---|---|
| D000077785 | Tenecteplase |
| ID | Term |
|---|---|
| D010959 | Tissue Plasminogen Activator |
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
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|
| 15 minutes after first dose |
| Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 30 minutes after first dose |
| Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 15 minutes after second dose |
| Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 30 minutes after second dose |
| Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | 120 minutes after second dose |
| Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following Administration of One or Two Doses of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Up to 120 minutes post-treatment (Dose 1 or Dose 2) |
| Percentage of Patients Who Had Cumulative Restoration Rates Restoration Rates of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Up to 7 days post-treatment |
| Years |
|
| Age, Customized | Number | participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | percentage of participants | 15 minutes after first dose |
|
|
|
| Secondary | Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Single Administration of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | percentage of participants | 30 minutes after first dose |
|
|
|
| Secondary | Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | percentage of participants | 15 minutes after second dose |
|
|
|
| Secondary | Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | percentage of participants | 30 minutes after second dose |
|
|
|
| Secondary | Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following a Second Administration of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | percentage of participants | 120 minutes after second dose |
|
|
|
| Secondary | Percentage of Patients Who Had Cumulative Restoration Rates of CVC Function Following Administration of One or Two Doses of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Modified intent to treat (MITT) population | Posted | Number | percentage of participants | Up to 120 minutes post-treatment (Dose 1 or Dose 2) |
|
|
|
| Secondary | Percentage of Patients Who Had Cumulative Restoration Rates Restoration Rates of CVC Function at Any Time During the Study and Who Maintained Catheter Patency the Next Time the Catheter Was Assessed, up to 7 Days Following the Last Dose of Tenecteplase | Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. | Number of patients (from MITT population) with restored CVC function during the treatment period | Posted | Number | percentage of participants | Up to 7 days post-treatment |
|
|
|
| 6 |
| 246 |
| 26 |
| 246 |
| Hypersensitivity | Immune system disorders |
|
| Catheter Related Infection | Infections and infestations |
|
| Device Malfunction | Injury, poisoning and procedural complications |
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| Dehydration | Metabolism and nutrition disorders |
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| Febrile Neutropenia | Blood and lymphatic system disorders |
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| Conjunctivitis | Eye disorders |
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| Eye Discharge | Eye disorders |
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| Nausea | Gastrointestinal disorders |
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| Abdominal Distension | Gastrointestinal disorders |
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| Abdominal Pain | Gastrointestinal disorders |
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| Constipation | Gastrointestinal disorders |
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| Diarrhoea | Gastrointestinal disorders |
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| Vomiting | Gastrointestinal disorders |
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| Pyrexia | General disorders |
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| Catheter Related Complication | General disorders |
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| Injection Site Erythema | General disorders |
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| Pain | General disorders |
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| Drug Hypersensitivity | Immune system disorders |
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| Graft Versus Host Disease | Immune system disorders |
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| Nasopharyngitis | Infections and infestations |
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| Otitis Media | Infections and infestations |
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| Rash Pustular | Infections and infestations |
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| Streptococcal Bacteraemia | Infections and infestations |
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| Bone Pain | Musculoskeletal and connective tissue disorders |
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| Muscle Spasms | Musculoskeletal and connective tissue disorders |
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| Neck Pain | Musculoskeletal and connective tissue disorders |
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| Dizziness | Nervous system disorders |
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| Dysuria | Renal and urinary disorders |
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| Urinary Retention | Renal and urinary disorders |
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| Increased Upper Airway Secretion | Respiratory, thoracic and mediastinal disorders |
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The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| D006867 |
| Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D010960 | Plasminogen Activators |
| D001779 | Blood Coagulation Factors |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |